Class II
Ongoing
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1
This recall is currently active, issued September 17, 2025. It was issued by Zydus Pharmaceuticals (Usa) Inc.
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- September 3, 2025
- Posted
- September 17, 2025
- Recall Number
- D-0630-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Pennington, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: Z403012, Exp Date 30-04-26; Z406657, Exp Date 30-11-26
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